Recall Z-1776-2024— Medtronic Navigation, Inc.

Name: FDA recall Z-1776-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-26

Class I · Ongoing

Class I FDA medical device recall by Medtronic Navigation, Inc., initiated 2024-03-26. It names one FDA 510(k) clearance: K162309. Product: Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.. Reason: Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2024-03-26
Firm location: Lafayette, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K162309 — StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc.·cleared 2017-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.

Reason for recall

Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.